Markers, Stainless Steel
FDA 510(k) K770802 · Cardio-Surgical, Inc.
510(k) numberK770802
Submission
- Device name
- Markers, Stainless Steel
- Applicant
- Cardio-Surgical, Inc.
Mchenry, IL, US - Received
- April 26, 1977
- Decision date
- June 27, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KPK – Marker, Ostia, Aorto-Saphenous Vein
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4650
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code KPK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K971966 | Coronary Vein Graft Tag MarkerKPK · Traditional | Med-Edge, Inc. | 01/26/1998SE |
| K895369 | Voss Graft MarkerKPK · Traditional | Voss Medical Products | 09/27/1989SE |
| K864919 | Scanlan (TM) Vein/Graft HolderKPK · Traditional | Scanlan Intl., Inc. | 01/12/1987SE |
| K864101 | Cook (R) Vein Graft Ring MarkersKPK · Traditional | Cook, Inc. | 10/30/1986SE |
| K801637 | Fluoro-Mark Radiopaque Anatomical Mkr.KPK · Traditional | C.R. Bard, Inc. | 08/27/1980SE |
Questions and answers
When was Markers, Stainless Steel cleared by the FDA?
Markers, Stainless Steel (K770802) received a 510(k) decision of Substantially Equivalent on June 27, 1977, 62 days after the submission was received.
What is the product code of K770802?
The FDA product code is KPK – Marker, Ostia, Aorto-Saphenous Vein, a Class II (moderate risk) device regulated under 21 CFR 878.4650.